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Influence of Trainning in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135924
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
Universidade do Estado do Pará
Information provided by (Responsible Party):
Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba

Brief Summary:

Parkinson's disease (PD) is a neurodegenerative disorder of the central nervous system (CNS), chronic and progressive that is associated with the loss of dopaminergic neurons in the compact part of the substantia nigra.

These patients often show excessive fatigue and dyspnea with the progression of the disease, and the later onset of treatment, lower the tolerance of the patient to perform physical activities.

Walking is one of the main limiting factors for a good quality of life. Therefore, gait training can promote individuals a better physical condition to recover their activities, as well as to maintain good posture, and reduce exacerbated flexion of the characteristic spine, preventing falls and various types of trauma. A proposed gait training is the Nordic walk, which, when using sticks to gain balance, stability and coordination, allows the individual to obtain better functional capacity, besides performing aerobic and stimulating activity.

In addition to the gait training, this research proposes respiratory muscle training (TMR), using a linear resistor capable of promoting resistance and strength gain of the inspiratory musculature. TMR is a therapeutic modality consecrated in the maximal inspiratory and expiratory pressure gain, directly influencing the peripheral musculature, favoring the practice of physical activities, such as walking itself to possibly condition the patient to longevity and dignity to practice their ADLs with better quality of life, allowing delayed disease progression.

In addition, the practice of these individuals submitted to walking and respiratory muscle training protocols can bring great benefits as regards their quality of life, and their perception of space, as well as their importance in the social environment. One form of evidence to qualify these aspects is the quality of life assessment scale in PDQ-39 Parkinson's Disease Patients, which contributes among other factors to the satisfaction and performance of the activity.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized clinical trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Trainning Respiratory Muscle About Gate and Physiological and Functional Variables in Parkinson's Disease
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: walking nordic and respiratory training group
It will be composed of patients with clinical diagnosis of Parkinson's disease, who will be submitted to respiratory muscle training (TMR) associated with the Nordic walking(NC) training .
Other: Rehabilitation
physical exercise and respiratory muscle training

Active Comparator: walking nordic group
It will be composed of patients with clinical diagnosis of Parkinson's disease, who will only be submitted to Nordic walking training.
Other: Rehabilitation
physical exercise and respiratory muscle training

Active Comparator: respiratory training group
It will be composed of patients with clinical diagnosis of Parkinson's disease, who will only be submitted to respiratory muscle training protocol.
Other: Rehabilitation
physical exercise and respiratory muscle training




Primary Outcome Measures :
  1. Measurement of lipid peroxidation [ Time Frame: 8 weeks ]
    Oxigen-reactive species

  2. Respiratory function [ Time Frame: 8 weeks ]
    spirometry variables analysis



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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • without cognitive impairment
  • Mini Mental State Examination with scores above 23
  • clinical diagnosis of Parkinson's disease in grade 2-3 on the scale modified Hoehn and Yarh

Exclusion Criteria:

  • volunteers who present cognitive, auditory and visual alterations, that incapacitate them to carry out the proposed procedure
  • carriers of Diabetes Mellitus and other metabolic diseases
  • heart disease and uncontrolled hypertension
  • ethyl alcohol
  • smoker
  • those hospitalized at least six months prior to the study
  • as well as those who do not use the medication and the correct dosage prescribed by the physician
  • individuals with osteomioarticular dysfunctions and neurological diseases
  • restricted to wheelchairs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135924


Contacts
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Contact: Larissa S Rocha, Phd +5591991209221 lari1980@gmail.com

Locations
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Brazil
Universidade do Estado do Pará Recruiting
Belém, Pará, Brazil, 66055-490
Contact: Rodrigo S Rocha, Phd    91992340234    fisiorocha2000@yahoo.com.br   
Sponsors and Collaborators
Universidade Metodista de Piracicaba
Universidade do Estado do Pará
Investigators
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Study Chair: Lucas M Matos, graduated Universidade do Estado do Pará
Publications of Results:
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Responsible Party: Rodrigo Santiago Barbosa Rocha, Phd, Director of Human Movement Department, Universidade Metodista de Piracicaba
ClinicalTrials.gov Identifier: NCT04135924    
Other Study ID Numbers: 031.819.852-52
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba:
Rehabilitation
Neurological disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases